DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Impo
Summary
The FDA issued a Class I for DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by DIBAR NUTRICIONAL S DE RL DE CV. Reason: Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol..
Details
Source
Drug Recall
External ID
D-0644-2021
Action Date
2021-07-07
Status
Terminated
Category
drug
Product Description
DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
Lot/Code Info: Lot # LDHSN050920 T1, LDHSN051020 DESC, LDHSN051020 T2, EXP 05/2022
Quantity Affected: Unknown quantity
Reason for Recall
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-11
Company
Morelia, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 19 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
DIBAR NUTRICIONAL S DE RL DE CV has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DIBAR NUTRICIONAL S DE RL DE CV) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DIBAR NUTRICIONAL S DE RL DE CV have FDA actions?
DIBAR NUTRICIONAL S DE RL DE CV has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0644-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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